Associate Director, CMC Regulatory Affairs

Vertex Pharmaceuticals • Boston, MA

14h • Hybrid

About The Position

The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. The role leads preparation and filing of regulatory CMC submissions and manages Health Authority interactions on CMC topics. It provides regulatory guidance to cross-functional teams and ensures applicable global regulatory requirements are considered and incorporated into investigational and commercial products. The role may supervise other regulatory staff.

The position also participates in department strategy design, development, and implementation, providing recommendations in its area of expertise. Vertex encourages continuous learning and thoughtful adoption of advances in AI, technology, automation, and industry trends to improve decision-making, innovation, efficiency, and outcomes for patients.

The role is hybrid-eligible or on-site eligible. Hybrid employees may work remotely up to two days per week; on-site employees work five days per week on-site, with ad hoc flexibility. Flex status is subject to Vertex policy and may change. The position has a base pay range of $166,400–$249,600 and is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay. Vertex benefits include medical, dental, and vision coverage; paid time off, including a week-long summer and winter company shutdown; educational assistance programs, including student loan repayment; a commuting subsidy; matching charitable donations; and a 401(k).

Requirements

• Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field.
• Typically requires 8 years of experience in the pharmaceutical or biotech industry or a related field, or an equivalent combination of education and experience.
• Advanced knowledge of FDA, EMA, Health Canada, and ICH regulatory guidelines.
• Excellent interpersonal skills to communicate difficult concepts and persuade others.
• Strategic thinking and strong problem-solving skills.
• Ability to collaborate and communicate openly, clearly, completely, promptly, and consistently.
• Strong planning and prioritization skills and ability to work with all levels of management.

Responsibilities

• Lead preparation and review of CMC sections of regulatory submissions, and manage interactions and responses with regulatory agencies.
• Develop global CMC regulatory strategies for one or more investigational and/or marketed products.
• Lead regulatory colleagues in developing global CMC regulatory strategies and submissions.
• Provide CMC regulatory guidance to cross-functional teams and key stakeholders.
• Manage regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations.
• Lead cross-functional projects and act as the primary regulatory CMC contact for assigned products and projects.
• Participate in designing, developing, and implementing department strategies, providing recommendations in the area of expertise.
• May supervise other regulatory staff.

Benefits

• Annual bonus and annual equity awards.
• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the summer and winter.
• Educational assistance programs, including student loan repayment.
• Commuting subsidy.
• Matching charitable donations.
• 401(k).
• Some roles may be eligible for overtime pay in accordance with federal and state requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Director